Boston Scientific

Boston Scientific — FDA 510(k) Submissions

Boston Scientific has submitted 57 FDA 510(k) premarket notifications since 2001, of which 51 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Stents, Drains And Dilators For The Biliary Ducts, Catheter, Percutaneous, Catheter, Angioplasty, Peripheral, Transluminal, Mechanical Thrombolysis Catheter, Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator . Use the specialty filter in the sidebar to narrow results.